Multi-layer thermal insulation blanket, operation methods and uses thereof

Abstract

The present disclosure relates to a multi-layer thermal insulation blanket, designed to protect the upper body, having as characteristics retaining the heat emitted by the patient and reusing it to keep the patient warm, namely to control or prevent Inadvertent Perioperative Hypothermia during surgery proceedings in the operating room.

Claims

1. A multi-layer thermal insulation blanket comprising: a fabric corresponding to a top protective layer comprising polyester and polyurethane for comfort; a fabric corresponding to an intermediate layer comprising polyester for warming; and a fabric corresponding to a bottom layer comprising polypropylene, polyamide and elastane for insulation wherein the layers overlap with each other to define a three-fabric sandwich structure, and wherein borders of the three-fabric sandwich structure are sealed by a seam.

2. The thermal insulation blanket according to claim 1, wherein the seam of the three-fabric sandwich structure comprises an in-fold of the layers.

3. The thermal insulation blanket according to claim 1, wherein the top protective layer consists of polyester and polyurethane for comfort, wherein the intermediate layer consists of polyester for warming, and wherein the bottom layer consists of polypropylene, polyamide, and elastane for insulation.

4. The thermal insulation blanket according to claim 1, wherein a thickness of the blanket is between 2-5 mm.

5. The thermal insulation blanket according to claim 1, wherein a weight of the blanket per area varies between 600-800 gr/m.sup.2.

6. The thermal insulation blanket according to claim 1, wherein the top layer comprises 70-80% (wt/wt) polyester and 20-30% (wt/wt) polyurethane.

7. The thermal insulation blanket according to claim 1, wherein the intermediate layer is polyester.

8. The thermal insulation blanket according to claim 1, wherein the intermediate layer is a polyester fiber, polyester foam, or a mixture thereof.

9. The thermal insulation blanket according to claim 1, wherein the bottom layer comprises 61% (wt/wt) polypropylene, 34% (wt/wt) polyamide, and 5% (wt/wt) elastane.

10. The thermal insulation blanket according to claim 1, wherein the blanket has a circular aperture near a lateral hedge to fit a patient's head.

11. The thermal insulation blanket according to claim 1, wherein the blanket has two sleeves with a closure system to maintain a temperature of a patient's arms.

12. The thermal insulation blanket according to claim 1, wherein the seam of the three-fabric sandwich structure comprises a lapped seam.

13. The thermal insulation blanket according to claim 1, wherein a thickness of the blanket is between 2.5-4.5 mm.

14. The thermal insulation blanket according to claim 1, wherein a thickness of the blanket is between 3-4 mm.

15. The thermal insulation blanket according to claim 1, wherein a weight of the blanket per area varies between 650-700 gr/m.sup.2.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The following figures and tables provide preferred embodiments for illustrating the description and should not be seen as limiting the scope of invention.

[0036] FIG. 1A: Schematic representation of a top view and perspective view of the embodiment.

[0037] FIG. 1B: Schematic representation of a lateral view of the previous embodiment.

[0038] FIG. 1C: Schematic representation of a cross sectional view of an exemplary embodiment of the present blanket.

[0039] FIG. 2: Schematic representation of a perspective view of the previous embodiment and functioning.

[0040] FIG. 3: Schematic representation of the ergonomic of the blanket and its measures.

[0041] FIG. 4: Graphic representation of the air permeability of top and intermediate layers.

[0042] FIG. 5: Graphic representation of the thermal conductivity of bottom layers.

TABLE-US-00001 TABLE 1 Thermal Insulation of sets of three layers. Table 1 - Thermal Insulation (Clo) Clo Type SERIAL PARALLEL 1 2.639 1.374 2 2.845 1.412 3 2.684 1.374 4 3.187 1.516 5 2.380 1.296 6 3.522 1.561 7 2.935 1.419 8 2.477 1.322

TABLE-US-00002 TABLE 2 Sample Characteristics Experiment Control Group Group Variable (n = 65) (n = 59) t(df) p Mean (SD) Mean (SD) Age 70.18 (8.10) 66.90 (6.71) 2.468 (122) 0.015 No Comorbidity 1.58 (1.07) 1.50 (0.95) 0.508 (122) ns Scholarity 4.60 (2.18) 4.24 (2.05) 0.953 (122) ns BMI 28.95 (4.16) 30.76 (4.10) 2.432 (122) 0.016 Fasting hours 11.40 (1.80) 11.61 (2.03) 1.371 (122) ns Systolic BP 142.40 (18.14) 142.20 (14.89) 0.072 (122) ns Diastolic BP 80.77 (9.92) 75.92 (11.66 2.504 (122) 0.014 Heart rate 69.52 (10.37) 69.07 (7.22) 0.286 (122) ns O.sub.2 Saturation 97.29 (1.72) 97.47 (1.28) 0.664 (122) ns Surgery time (min) 72.46 (13.59) 69.32 (12.40) 1.339 (122) ns Number (%) Number (%) Female (number %) 55 (84.6) 48 (81.4) ns ASA Classification I 4 (6.2) 3 (5.1) ns II 61 (93.8) 51 (93.2) ns III 0 (0) 1 (1.7) ns SD—Standard Deviation; ASA—American Society of Anaesthesiologists; df—degrees of freedom

TABLE-US-00003 TABLE 3 Temperature Variation and Thermal Comfort Visual Perception Experiment Control Group Group (n = 65) (n = 59) M(SD) M(SD) t(df) p Temperature T1 36.59 (0.22) 36.59 (0.26) 0.026 (122) ns T2 36.34 (0.20) 36.33 (0.22) 0.820 (122) ns T3 36.28 (0.18) 36.30 (0.20) 0.221 (122) ns T4 36.27 (0.17) 36.29 (0.21) 0.615 (122) ns T5 36.25 (0.16) 36.32 (0.20) 1.869 (122) ns T6 36.28 (0.19) 36.35 (0.22) 1.963 (122) ns Visual perception of the thermic comfort T1  4.80 (0.44)  4.90 (0.31) 1.456 (122) ns T2  5.00 (0.00)  4.95 (0.22) 1.176 (122) ns T3  5.00 (0.00)  5.00 (0.00) — ns T4  4.97 (0.25)  5.05 (0.22) 1.925 (122) ns T5  5.00 (0.00)  4.98 (0.13) 1.000 (122) ns T6  5.00 (0.00)  5.00 (0.00) — ns M—Mean; SD—Standard Deviation; df—degrees of freedom

TABLE-US-00004 TABLE 4 Thermal Comfort Scale scores Experiment Control Group Group (n = 65) (n = 59) M(SD) M(SD) t(df) p Physical Dimension 26.75 (2.39) 27.25 (2.23) 1.203 (122) ns Emotional Dimension 12.27 (1.51) 12.78 (1.19) 0.293 (122) ns Total 39.46 (3.59) 40.03 (2.88) 0.974 (122) ns TCS—thermic comfort scale; M—Mean; SD—Standard Deviation; df—degrees of freedom

TABLE-US-00005 TABLE 5 Perioperative Comfort Scale scores Experiment Control Group Group (n = 65) (n = 59) M(SD) M(SD) t(df) p Relieve 25.89 (2.19) 26.41 (2.59) 1.199 (122) ns Ease 16.71 (2.18) 16.86 (1.85) 0.429 (122) ns Transcendency 21.09 (2.02) 21.47 (1.99) 1.061 (122) ns Total 59.12 (5.44) 60.20 (5.06) 1.141 (122) ns TCS—thermic comfort scale; M—Mean; SD—Standard Deviation; df—degrees of freedom

TABLE-US-00006 TABLE 6 Comparison of Ergonomic Comfort between groups Experiment Control Group Group (n = 65) (n = 59) M(SD) M(SD) t(df) p Body adjustment 4.40 (0.55) 4.10 (0.58) 2.928 (122) 0.04 Weight 4.46 (0.50) 4.31 (0.50) 1.376 (122) ns Neck comfort 4.43 (0.50) 4.03 (0.59) 4.039 (122) 0.0001 Arm comfort 4.45 (0.50) 4.03 (0.59) 4.340 (122) 0.0001 Abdomen comfort 4.43 (0.50) 4.15 (0.49) 3.148 (122) 0.02 All zones comfort 4.45 (0.50) 4.19 (0.47) 2.786 (122) 0.04 Touch 4.38 (0.49) 4.15 (0.41) 2.876 (122) 0.005 Inner layer texture 4.46 (0.50) 4.12 (0.42) 4.142 (122) 0.0001 Colour 4.32 (0.53) 4.27 (0.49) 0.567 (122) ns Shape 4.43 (0.53) 4.07 (0.53) 3.799 (122) 0.0001 M—Mean; SD—Standard Deviation; df—degrees of freedom

DETAILED DESCRIPTION

[0043] The present disclosure relates to a multi-layer thermal insulation blanket, designed to protect the upper body, having as characteristics retaining the heat emitted by the patient and reusing it to keep the patient warm, namely to control or prevent Inadvertent Perioperative Hypothermia during surgery proceedings in the operating room.

[0044] FIG. 1A shows a schematic representation of a top and perspective view of the complete blanket where: 11 represents the bottom layer, 12 represents the intermediate layer, and 13 represents the top layer.

[0045] FIG. 1B shows a schematic representation of a lateral view of the three layers.

[0046] FIG. 1C shows a cross sectional view of the layers of the blanket, applicated to the patient.

[0047] FIG. 2 shows a schematic representation of a perspective view of the three layers and its functioning: the air and water movement 21 and the heat movement 22.

[0048] In order to assess the thermal properties of the textile materials, tests were made with all the samples: one top layer, one intermediate layer and eight different fabrics to choose the bottom layer. In the first phase, the Air Permeability was tested in the bottom and intermediate layers. Thermal Conductivity (property that provide the hot / cool sensation) was tested in the bottom layers, to find the more comfortable one. In the second phase, the Thermal Insulation capacity of sets of three layers was tested. Two different models were used to calculate the results of the Thermal Insulation tests (Serial Model and Parallel Model).

[0049] The results of testing Air Permeability show that the top layer permeability is very low, whereas that of the intermediate layer is very high, as expected (FIG. 4). Relative to the bottom layers, the results suggest that the best results in terms of Thermal Conductivity were for the sample of polypropylene, polyamide and elastane as shown in FIG. 5. The set of three layers comprised of the polypropylene, polyamide and elastane bottom layer showed the best results in terms of Thermal Insulation as shown in FIG. 5. This set was chosen for the structure of the present blanket.

[0050] The following data compared the effectiveness of the three-layered thermal insulation blanket of the present disclosure versus the traditional thermal body protection (warmed forced air system) for patients under total knee arthroplasty, during the intraoperative phase.

TABLE-US-00007 Randomized Controlled Study Intervention/treatment Control Group (n = 59) Warmed forced air system Intervention Group (n = 65) Three layered thermal insulation blanket of the present disclosure

[0051] Participants were randomly assigned to the experimental group or control group. The experimental group received as a skin protection the three-layer thermal insulation blanket of the present disclosure and the control group received the usual recommended system (warmed forced air).

[0052] Both blankets were placed at the entrance to the operating room and held on patients during the entire intraoperative phase.

[0053] In order to understand the variation of the study variables, and their relation to the baseline values (T1), measured at the entrance of the surgical department, the tympanic temperature, the visual perception of thermal comfort and shivering were evaluated at different moments until the exit of the operating room.

[0054] In addition, thermal and general subjective dimensions of perioperative comfort were evaluated, thirty minutes after beginning surgery (T4). Aspects of ergonomic comfort have also been assessed.

[0055] The results have shown significant differences were found between groups, relative to the mean age (EG−70.18 SD 8.10, CG−66.90 SD 6.71, p=0.015), body mass index (EG−28.95 SD 4.16, CG−30.76 SD 4.10, p=0.016) and diastolic blood pressure (EG−80.77 SD 9.92, CG−75.92 SD 11.66, p=0.014) FIG. 6. Shivering was not observed. Differences in mean temperature variation and thermal comfort visual perception were not statistically significant between groups (p <0.0001) in the six evaluation times as shown in Table 3. The values of the thermal comfort scales scores (EG−39.46 SD 3.59, CG−40.03 SD 2.88, p>0.05) as shown in Table 4, and perioperative comfort (EG−59.12 SD 5.44, CG−60.20 SD 5.06, p>0.05), as shown in Table 5, also didn't show statistically significant differences. The new system has proven to be more ergonomic than the usual system. The results suggest that the three-layer insulation system developed has a similar effect to the warmed forced air system, temperature variation and intraoperative comfort perception, indicating that it is suitable for use in the perioperative context.

[0056] The term “comprising” whenever used in this document is intended to indicate the presence of stated features, integers, steps, components, but not to preclude the presence or addition of one or more other features, integers, steps, components or groups thereof. The disclosure should not be seen in any way restricted to the embodiments described and a person with ordinary skill in the art will foresee many possibilities to modifications thereof.

[0057] The above described embodiments are combinable. The following claims further set out particular embodiments of the disclosure.